Chr t(11;14)

P2, N=32, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting | N=50 --> 32

P2, N=120, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting | Trial completion date: Dec 2027 --> Jun 2027 | Trial primary completion date: Dec 2027 --> Jun 2027

P2, N=15, Completed, SCRI Development Innovations, LLC | Active, not recruiting --> Completed | Trial completion date: Aug 2027 --> Apr 2024 | Trial primary completion date: Aug 2027 --> Apr 2024

Lastly, we show for the first time in primary MM patient samples, that 5-azacytidine enhances the response to venetoclax ex-vivo, across diverse anti-apoptotic dependencies (BCL-2 or MCL-1) and diverse cytogenetic backgrounds. Overall, our data identifies 5-azacytidine and venetoclax as an effective treatment combination and this could be a tolerable steroid-sparing regimen, particularly for elderly MM patients.

P2, N=23, Active, not recruiting, Emory University | Trial primary completion date: Sep 2023 --> Sep 2024

P2, N=30, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2024 --> Jun 2024

P1/2, N=30, Recruiting, Chinese PLA General Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025

P1, N=100, Recruiting, Mayo Clinic | Not yet recruiting --> Recruiting

P1, N=7, Completed, Mayo Clinic | Active, not recruiting --> Completed

P1, N=72, Recruiting, Emory University | Trial completion date: Feb 2026 --> Feb 2027

P3, N=547, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025

At the Lymphoma Research Foundation's 20th MCL Scientific Consortium and Workshop, researchers gathered to discuss recent developments in both basic scientific and clinical research to continue to develop an understanding of MCL and improve outcomes for patients. This report, which includes a summary of each presentation, reviews the findings presented at the workshop and highlights opportunities, open questions, and areas for future study that would pave the way for a cure for this disease in the coming decades.

P1/2, N=33, Recruiting, Han weidong | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=15, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024

P3, N=523, Active, not recruiting, Janssen Research & Development, LLC | Trial completion date: Dec 2025 --> May 2024

P1, N=28, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jan 2024 --> Jan 2025

P1/2, N=39, Recruiting, University of Utah | Suspended --> Recruiting

P2, N=81, Active, not recruiting, Nordic Lymphoma Group | Recruiting --> Active, not recruiting

P3, N=265, Active, not recruiting, AbbVie | Recruiting --> Active, not recruiting

P2, N=37, Completed, Roswell Park Cancer Institute | Active, not recruiting --> Completed

P1, N=360, Recruiting, AbbVie | Trial completion date: Apr 2026 --> Aug 2026 | Trial primary completion date: Apr 2026 --> Aug 2026

P2, N=39, Not yet recruiting, Oncotherapeutics | Initiation date: Dec 2023 --> Mar 2024

P2, N=124, Active, not recruiting, Acerta Pharma BV | Trial completion date: Dec 2025 --> Sep 2026

P2, N=100, Recruiting, Academic and Community Cancer Research United | Not yet recruiting --> Recruiting

P1/2, N=43, Completed, PrECOG, LLC. | Active, not recruiting --> Completed | Trial completion date: Jul 2024 --> Sep 2023

P1/2, N=46, Recruiting, Alfred Chung, MD | Not yet recruiting --> Recruiting

P2, N=50, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2025 --> Feb 2026 | Trial primary completion date: Feb 2025 --> Feb 2026

P2, N=50, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025

P2, N=100, Recruiting, AstraZeneca | Not yet recruiting --> Recruiting

Venetoclax is a B-cell lymphoma 2 (Bcl-2) inhibitor with activity in patients with t(11;14) and/or Bcl-2 expression. Iberdomide and mezigdomide are cereblon E3 ligase modulators with higher potency, immunomodulatory, and antiproliferative activity compared with lenalidomide and pomalidomide...Modakafusp alfa is an immunocytokine that targets interferons to CD38+ cells. It has demonstrated single agent activity in relapsed/refractory MM in the phase 1 setting.

P2, N=394, Recruiting, AbbVie | Trial completion date: May 2029 --> Nov 2032 | Trial primary completion date: May 2029 --> Nov 2032

IgM monoclonal gammopathies such as IgM myeloma and Waldenström macroglobulinaemia are distinct haematological conditions; however, differentiating between these entities can often present as a challenge.In this review, we explore the challenging diagnosis and treatment of IgM myeloma in a patient presenting with unexplained macrocytic anaemia, elevated serum protein and IgM levels in the absence of t(11;14) and lytic bone lesions that are classically associated with the diagnosis of IgM myeloma. The diagnosis was established based on 40% monoclonal plasma cell population on a bone marrow biopsy, gain of 1q21 on fluorescence in situ hybridisation, cyclin D1 positivity and absence of MYD88 mutation.

P1, N=100, Not yet recruiting, Mayo Clinic | Trial completion date: Sep 2028 --> Dec 2028 | Trial primary completion date: Sep 2028 --> Dec 2028

P1/2, N=167, Recruiting, BeiGene | Phase classification: P1b/2 --> P1/2

P1, N=18, Active, not recruiting, City of Hope Medical Center | Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024

Later, several studies in RRMM patients that used venetoclax in combination with dexamethasone or/and proteasome inhibitors have shown promising results, in which management guidelines have included venetoclax as one of the options to treat MM patients. Hence, this review focuses on the use of venetoclax in RRMM, clinical efficacy, safety, dosing strategies, and predictive biomarkers for initiating venetoclax. Additionally, we discuss ongoing studies that are investigating different combination of venetoclax regimens in MM patients.

P1/2, N=46, Not yet recruiting, Alfred Chung, MD | N=78 --> 46 | Trial completion date: Aug 2027 --> Dec 2027 | Trial primary completion date: Aug 2027 --> Dec 2027

P2, N=30, Active, not recruiting, AstraZeneca | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Aug 2023

Venetoclax demonstrates promising results. When given with drugs like dexamethasone, daratumumab and carfilzomib, a synergistic effect is seen in treating translocation (11:14) positive relapsed/refractory MM. The use of venetoclax in clinical practice can potentially improve outcomes and quality of life in RRMM patients, and future research should continue to explore this promising treatment option.

P1/2, N=54, Active, not recruiting, Incyte Corporation | Phase classification: P1b/2a --> P1/2 | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2023 --> Dec 2024

P1/2, N=23, Suspended, City of Hope Medical Center | Trial completion date: Dec 2023 --> Nov 2024 | Recruiting --> Suspended | Trial primary completion date: Dec 2023 --> Nov 2024

P1/2, N=135, Active, not recruiting, K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting